Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy (GENIUS trial): a placebo-controlled, double-blind, randomized phase III study
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| 024 | 7 | 0 | |a 10.1007/s10147-015-0784-9 |2 doi |
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| 245 | 0 | 0 | |a Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy (GENIUS trial): a placebo-controlled, double-blind, randomized phase III study |h [Elektronische Daten] |c [Eiji Oki, Yasunori Emi, Hiroshi Kojima, Jun Higashijima, Takeshi Kato, Yasuhiro Miyake, Masanori Kon, Yutaka Ogata, Kenichi Takahashi, Hideyuki Ishida, Hiroshi Saeki, Yoshihisa Sakaguchi, Takeharu Yamanaka, Toru Kono, Naohiro Tomita, Hideo Baba, Ken Shirabe, Yoshihiro Kakeji, Yoshihiko Maehara] |
| 520 | 3 | |a Background: Peripheral sensory neurotoxicity is a frequent adverse effect of oxaliplatin therapy. Calcium and magnesium (Ca/Mg) infusions are frequently used as preventatives, but a recent phase III trial failed to show that they prevent neurotoxicity. We therefore conducted a multicenter randomized phase III trial to compare fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) with and without Goshajinkigan (GJG), a traditional Japanese herbal medicine (Kampo), to determine GJG's potential for reducing peripheral neuropathy in patients with colorectal cancer. Methods: Patients with colon cancer who were undergoing adjuvant therapy with infusional mFOLFOX6 were randomly assigned to GJG (7.5mg three times daily) or placebo in a double-blind manner. The primary endpoint was the time to grade 2 or greater neuropathy, which was determined at any point during or after oxaliplatin-based therapy using version 3 of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Findings: An interim analysis was performed when 142 of the planned 310 patients had been enrolled and the safety assessment committee recommended that the study be discontinued. One hundred eighty-two patients were evaluable for response. They included 89 patients in the GJG group and 93 patients in the placebo group. The incidence of grade 2 or greater neurotoxicity was 50.6% in the GJG group and 31.2% in the placebo group. A Cox proportional hazards analysis indicated that the use of GJG was significantly associated with the incidence of neuropathy (hazard ratio, 1.908; p=0.007). Conclusion: Goshajinkigan did not prevent oxaliplatin-associated peripheral neuropathy in this clinical trial. The clinical study was therefore terminated. | |
| 540 | |a Japan Society of Clinical Oncology, 2015 | ||
| 690 | 7 | |a Adjuvant chemotherapy |2 nationallicence | |
| 690 | 7 | |a Colon cancer |2 nationallicence | |
| 690 | 7 | |a Colorectal cancer |2 nationallicence | |
| 690 | 7 | |a Goshajinkigan |2 nationallicence | |
| 690 | 7 | |a Herbal medicine, Kampo |2 nationallicence | |
| 690 | 7 | |a Peripheral neuropathy |2 nationallicence | |
| 700 | 1 | |a Oki |D Eiji |u Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan |4 aut | |
| 700 | 1 | |a Emi |D Yasunori |u Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan |4 aut | |
| 700 | 1 | |a Kojima |D Hiroshi |u Department of Gastroenterological Surgery, Aichi Cancer Center Aichi Hospital, Nagoya, Japan |4 aut | |
| 700 | 1 | |a Higashijima |D Jun |u Department of Digestive and Pediatric Surgery, Faculty of Medicine, University of Tokushima, Tokushima, Japan |4 aut | |
| 700 | 1 | |a Kato |D Takeshi |u Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan |4 aut | |
| 700 | 1 | |a Miyake |D Yasuhiro |u Department of Surgery, Minoh City Hospital, Minoh, Japan |4 aut | |
| 700 | 1 | |a Kon |D Masanori |u Department of Surgery, Kansai Medical University, Osaka, Japan |4 aut | |
| 700 | 1 | |a Ogata |D Yutaka |u Department of Surgery, Kurume University Medical Center, Kurume, Japan |4 aut | |
| 700 | 1 | |a Takahashi |D Kenichi |u Department of Surgery, Aomori Prefectural Central Hospital, Aomori, Japan |4 aut | |
| 700 | 1 | |a Ishida |D Hideyuki |u Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical School, Saitama, Japan |4 aut | |
| 700 | 1 | |a Saeki |D Hiroshi |u Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan |4 aut | |
| 700 | 1 | |a Sakaguchi |D Yoshihisa |u Department of Gastroenterological Surgery, Kyushu National Medical Center, Fukuoka, Japan |4 aut | |
| 700 | 1 | |a Yamanaka |D Takeharu |u Department of Biostatistics, Yokohama City University, Yokohama, Japan |4 aut | |
| 700 | 1 | |a Kono |D Toru |u Sapporo Higashi Tokushukai Hospital, Sapporo, Japan |4 aut | |
| 700 | 1 | |a Tomita |D Naohiro |u Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan |4 aut | |
| 700 | 1 | |a Baba |D Hideo |u Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan |4 aut | |
| 700 | 1 | |a Shirabe |D Ken |u Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan |4 aut | |
| 700 | 1 | |a Kakeji |D Yoshihiro |u Department of Gastrointestinal Surgery, Kobe University, Kobe, Japan |4 aut | |
| 700 | 1 | |a Maehara |D Yoshihiko |u Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan |4 aut | |
| 773 | 0 | |t International Journal of Clinical Oncology |d Springer Japan |g 20/4(2015-08-01), 767-775 |x 1341-9625 |q 20:4<767 |1 2015 |2 20 |o 10147 | |
| 856 | 4 | 0 | |u https://doi.org/10.1007/s10147-015-0784-9 |q text/html |z Onlinezugriff via DOI |
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| 900 | 7 | |a Metadata rights reserved |b Springer special CC-BY-NC licence |2 nationallicence | |
| 908 | |D 1 |a research-article |2 jats | ||
| 949 | |B NATIONALLICENCE |F NATIONALLICENCE |b NL-springer | ||
| 950 | |B NATIONALLICENCE |P 856 |E 40 |u https://doi.org/10.1007/s10147-015-0784-9 |q text/html |z Onlinezugriff via DOI | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Oki |D Eiji |u Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Emi |D Yasunori |u Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kojima |D Hiroshi |u Department of Gastroenterological Surgery, Aichi Cancer Center Aichi Hospital, Nagoya, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Higashijima |D Jun |u Department of Digestive and Pediatric Surgery, Faculty of Medicine, University of Tokushima, Tokushima, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kato |D Takeshi |u Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Miyake |D Yasuhiro |u Department of Surgery, Minoh City Hospital, Minoh, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kon |D Masanori |u Department of Surgery, Kansai Medical University, Osaka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Ogata |D Yutaka |u Department of Surgery, Kurume University Medical Center, Kurume, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Takahashi |D Kenichi |u Department of Surgery, Aomori Prefectural Central Hospital, Aomori, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Ishida |D Hideyuki |u Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical School, Saitama, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Saeki |D Hiroshi |u Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Sakaguchi |D Yoshihisa |u Department of Gastroenterological Surgery, Kyushu National Medical Center, Fukuoka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Yamanaka |D Takeharu |u Department of Biostatistics, Yokohama City University, Yokohama, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kono |D Toru |u Sapporo Higashi Tokushukai Hospital, Sapporo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Tomita |D Naohiro |u Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Baba |D Hideo |u Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Shirabe |D Ken |u Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kakeji |D Yoshihiro |u Department of Gastrointestinal Surgery, Kobe University, Kobe, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Maehara |D Yoshihiko |u Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 773 |E 0- |t International Journal of Clinical Oncology |d Springer Japan |g 20/4(2015-08-01), 767-775 |x 1341-9625 |q 20:4<767 |1 2015 |2 20 |o 10147 | ||